Multiple Dose Vial and Method

ABSTRACT

A vial for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices. The vial has a body, a storage chamber within the body for storing multiple doses of the substance therein, a sterile filter configured to sterilize air or other gas flowing into the storage chamber through the filter, and a one-way valve connectable in fluid communication with a syringe or other delivery device. The one-way valve is moveable relative to the body between first and second positions (i) one of which permits the valve to open so that substance from the storage chamber can flow therethrough and into the syringe or other delivery device connected in fluid communication therewith, and (ii) one of which prevents the valve from opening.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of co-pending U.S. patentapplication Ser. No. 13/744,379, filed Jan. 17, 2013, entitled “MultipleDose Vial and Method,” now U.S. Pat. No. 9,801,787, issued Oct. 31,2017, which claims priority to similarly-titled U.S. Provisional PatentApplication No 61/587,525, filed Jan. 17, 2012, all of which are herebyincorporated by reference in its entirety as part of the presentdisclosure.

SUMMARY OF THE INVENTION

The present invention relates to fluid storage and dispensing devices,such as vials, and more particularly, to such devices for storingmultiple doses of the substances to be dispensed.

BACKGROUND INFORMATION

A typical vial, such as a medicament vial, includes a vial body defininga chamber for storing a substance to be dispensed, such as a medicament,and a needle-penetrable stopper received within a mouth of the vial bodythat seals the medicament or other substance within the chamber. Inorder to withdraw the substance from the vial, the following steps aretypically performed. First, the physician or the nurse must fill thesyringe with air, and such air, particularly from a hospital, is notsterile. Second, the stopper must be pierced with the syringe needle inorder to place the needle tip in fluid communication with the vialchamber. Third, the non-sterile air from the syringe is injected intothe vial with enough pressure for the compressed air to replace thevolume of liquid pulled into the syringe. Fourth, the vial is put upsidedown, with the syringe needle vertically beneath the vial, for theliquid of the vial to be drained from the open end of the needle. Then,the plunger of the syringe is pulled vertically downward to, in turn,draw the liquid into the syringe through the immerged tip of the needlein the upside-down vial. Once the syringe is filled, if air has beendrawn into the syringe, it is forced out by pushing the plunger with thesyringe in the upside-down position in order to eject any air up to thefirst drop of liquid pushed into the syringe needle. Then, the syringeis used to inject the withdrawn medicament or other substance into, orto otherwise administer it to, a patient.

One of the drawbacks of such a typical known vial is that each time thestopper is pierced with a syringe needle to withdraw a dose ofmedicament or other substance, the syringe has to be pre-filled withcontaminated air from the environment. The needle also can accidentallycontact the fingers of the medical personnel or other contaminatedsurfaces and, as a result, introduce more germs, bacteria or othercontaminants into the vial chamber.

A second drawback is that the air injected during previous withdrawalsfrom a multiple dose vial can lead to the reproduction of germsinitially contained in the air and injected into the vial. The firstwithdrawal of the liquid out of a multiple dose vial may be contaminatedby the ambient air initially injected into the vial as described above,but between the air injection into the vial and the withdrawal of theliquid, there is not enough time for the germs contained in the air toreproduce in many colonies. However, it can be increasingly dangerous towithdraw liquid from that vial when the amount of dose already withdrawnhas been in contact with the germs of previous injections of air intothe vial. Accordingly, such vials cannot be safely used to dispensemultiple doses of the medicament or other substance without risk ofcontaminating the substance remaining within the vial chamber aftermultiple doses have been withdrawn.

A third drawback of the traditional method is that the needle mayaccidentally stick the skin of the medical personnel, and as a result,may transfer to the patients, contaminants from the blood of the medicalpersonnel, such as hepatitis, a professional disease of medicalpersonnel in general, AIDS, or other ailments.

Yet another drawback is due to the needle transfer when medicalpersonnel withdraw the needle from the vial after the syringe has beenfilled. At that time the finger of the physician or nurse can beaccidentally stuck by the needle and thereby infected with a productcontaminated by germ growth in the multiple dose container.

SUMMARY OF THE INVENTION

It is an object of the present invention to overcome one or more of theabove- described drawbacks and/or disadvantages of the prior art. Inaccordance with a first aspect, a device for storing multiple doses of asubstance to be dispensed into one or more syringes or other deliverydevices comprises a body, a storage chamber within the body for storingmultiple doses of the substance therein; and a valve, such as a one-wayvalve, connectable in fluid communication with a syringe or otherdelivery device and moveable between first and second positions, andhaving a closed position preventing substance from passing therethroughand an open position permitting substance to pass therethrough. In thefirst position the one-way valve is prevented from opening into the openposition and substance from the storage chamber cannot passtherethrough, and in the second position the one-way valve is permittedto open into the open position so that the one-way valve permitssubstance from the storage chamber to flow therethrough and into thesyringe or other delivery device connected in fluid communicationtherewith.

In some embodiments, the device includes a sterile filter coupled influid communication between the storage chamber and ambient atmosphere,and the sterile filter is configured to allow air or other gas to flowfrom the ambient atmosphere therethrough into the storage chamber, andto sterilize air or other gas flowing into the storage chamber throughthe filter.

In some embodiments, the one-way valve is configured to substantiallyprevent any fluid flow in a substantially opposite direction, from thesyringe or other delivery device, therethrough, and into the storagechamber.

In some embodiments, the one-way valve includes an elastic valve memberdefining a normally closed, valve seam that substantially prevents thepassage of fluid therethrough when a pressure differential across thevalve is less than a valve opening pressure, and allows the passage offluid therethrough when a pressure differential across the valve exceedsthe valve opening pressure. In some such embodiments, the one-way valveincludes a valve seat, and the elastic valve member engages the valveseat and forms the valve seam therebetween. In some such embodiments,(i) the elastic valve member defines a progressively decreasing wallthickness in a direction from an inlet toward an outlet of the valveseam, and/or (ii) the valve seat defines a progressively increasingwidth or diameter in a direction from an inlet toward an outlet of thevalve seam.

In some embodiments, the device includes a penetrable and resealableportion or septum that is penetrable by a needle, filling or injectionmember for filling the storage chamber with substance to be dispensed,and is resealable to hermetically seal a resulting penetration aperturein the septum. In some such embodiments, the septum is resealable by aliquid sealant, radiation, and/or the application of thermal energythereto.

In some embodiments, the one-way valve is normally biased in a directionfrom the second position toward the first position. In some suchembodiments, the device includes a spring that normally biases theone-way valve in the direction from the second position toward the firstposition. In some embodiments, the spring is an elastic spring, such asan approximately dome-shaped spring or an approximately bellows-shapedspring.

In some embodiments, (i) in the first position, the one-way valve isengaged with a surface of the device that substantially prevents theone-way valve from opening into the open position, and (ii) in thesecond position, the one-way valve is sufficiently disengaged from thesurface of the device to permit the valve to open into the openposition. In some embodiments, the one-way valve includes a valve seatand a valve member normally engaging the valve seat to define the closedposition, the valve member being movable relative to the valve seat whena pressure differential across the one-way valve exceeds a valve openingpressure thereof. In the first position, the surface of the devicesubstantially prevents movement of the valve member relative to thevalve seat. In the second position, the valve member is sufficientlydisengaged from the surface to permit movement of the valve memberrelative to the valve seat. In some such embodiments, the surface of thevial engageable with the valve member extends substantially annularlyabout the valve member.

Some embodiments further comprise a connector located adjacent (e.g.,downstream) to an outlet of the one-way valve. The connector is adaptedto connect thereto the syringe or other delivery device. In someembodiments, the connector is a Luer connector. In some embodiments,connection of the syringe or other delivery device to the connectorcauses the valve to move in the direction from the first position to thesecond position. In some such embodiments, the connector defines asurface of the vial engageable with the valve member in the firstposition to prevent valve opening. In some embodiments, the one-wayvalve includes a valve seat, and the syringe or other delivery deviceengages the valve seat to cause the valve to move in a direction fromthe first position toward the second position.

In some embodiments, the storage chamber is hermetically sealed withrespect to ambient atmosphere, is sterile, and includes therein multipledoses of a sterile or aseptic substance. The one-way valve substantiallyprevents fluid and germ ingress, such as air, therethrough and into thestorage chamber.

In some embodiments, the body includes a sliding seal received thereinand spaced relative to the one-way valve, wherein the storage chamber isa variable-volume storage chamber defined within the body between thesliding seal and the one-way valve.

In some embodiments, the devices further comprises a base closuresealingly enclosing the body at an opposite side of the body from theone-way valve, and a flexible bladder integrally formed with the baseclosure and projecting therefrom toward the one-way valve, wherein thestorage chamber is a variable-volume storage chamber defined between theflexible bladder and the body. In some such embodiments, the flexiblebladder is configured to collapse when the variable-volume storagechamber is filled and expands when substance is dispensed from thevariable-volume storage chamber.

In accordance with another aspect, a device for storing multiple dosesof a substance to be dispensed into one or more syringes or otherdelivery devices comprises first means for storing therein multipledoses of the substance, second means for coupling in fluid communicationwith a syringe or other delivery device and for moving between first andsecond positions, and for preventing substance from passing through thesecond means in a closed position and for permitting substance to passthrough the second means in an open position, and third means forpreventing the second means from opening into the open position in thefirst position, and for permitting the second means to open into theopen position in the second position.

Some embodiments further include fourth means for penetrating with aneedle, filling or injection member, and sterile or aseptic filling thesubstance into the first means. In some such embodiments, the thirdmeans is a penetrable and resealable portion or septum.

Some embodiments include means for sterile or aseptic filling thesubstance into the first means comprising a smooth and non-piercingprobe for injecting the fluid through a one-way valve, including a valvecomprising a depressible, approximately dome-shaped spring, or othertype of elastic spring, with mechanical self-closing properties, afterfilling and withdrawal of the probe.

Some embodiments further comprise fifth means for connecting thereto thesyringe or other delivery device. Some embodiments further comprisesixth means for biasing the second means in the direction from the firstposition toward the second position. In some embodiments, the firstmeans is a storage chamber (defining either a fixed or variable volume),the second means is a one-way valve, the fifth means is a connector, thesixth means is a spring, the third means is a surface of a body of thedevice and/or a connector that is engageable with the one-way valve inthe first position.

In accordance with another aspect, a method comprises the followingsteps:

i. storing multiple doses of a substance to be dispensed in a storagechamber and sealing the stored multiple doses with respect to ambientatmosphere;ii. connecting a syringe or other delivery device in fluid communicationwith a one-way valve in fluid communication with the storage chamber;iii. dispensing a dose of substance from the storage chamber through theone-way valve and into the syringe or other delivery device;iv. substantially preventing ambient fluid from passing through theone-way valve and into the storage chamber during step iii; andv. repeating steps ii through iv with the same multiple dose device.

In some embodiments, step (iii) includes creating at least a partialvacuum in the syringe or other delivery device and, in turn, creating apressure differential across the one-way valve that exceeds a valveopening pressure thereof. Some embodiments further include, during orafter step ii, moving the one-way valve from (i) a first position wherethe one-way valve is prevented from opening into an open positionwherein substance may pass therethrough, to (ii) a second position wherethe one-way valve is permitted to open into the open position andsubstance may pass therethrough. Some embodiments further includeengaging the one-way valve with the syringe or other delivery device,and moving the one-way valve in the direction from the first positiontoward the second position during or after connecting the syringe orother delivery device to the multiple dose device. Some embodimentsfurther comprise maintaining the substance in the storage chamberhermetically sealed with respect to ambient atmosphere throughout stepsi through iv. Some such embodiments further comprise maintaining thesubstance in the storage chamber sterile or aseptic throughout steps ithrough iv.

One advantage of the present invention is that the multiple dose device,such as the multiple dose vial, can safely dispense multiple doses of amedicament or other substance without risk of contaminating thesubstance remaining within the storage chamber after one or more dosesare withdrawn, or without the risk of cross-contamination betweenpatients treated with medicament or other substance from the samedevice. Yet another advantage is that the one-way valve cansubstantially prevent air and germs from passing through the one-wayvalve and into the storage chamber, such as during dispensing multipledoses of substance from the storage chamber into a syringe or otherdelivery device. Yet another advantage is that the device can maintainthe substance stored in the storage chamber, such as a medicament,pharmaceutical, vaccine, liquid nutrition product or supplement, sealedwith respect to ambient atmosphere and sterile and/or aseptic throughdispensing of multiple doses from the device. Yet another advantage isthat the device can allow for needleless transfer of doses of substance,such as a medicament, from the device to a syringe, such as through aLuer connection. Yet another advantage is that the device cansubstantially prevent any ambient or otherwise contaminated air frombeing injected into the chamber of the device containing the remainingdoses of substance to be dispensed.

Other objects and advantages of the present invention, and/or of thecurrently preferred embodiments thereof, will become more readilyapparent in view of the following detailed description of currentlypreferred embodiments and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a multiple dose vial;

FIG. 2A is an exploded, perspective view of the variable-volume storagechamber, closure and one-way valve of the multiple dose vial of FIG. 1;

FIG. 2B is a perspective view of the assembled variable-volume storagechamber, closure and one-way valve, and illustrating the manner in whichthe assembly is inserted into the body of the multiple dose vial of FIG.1;

FIG. 3 is a cross-sectional view of the multiple dose vial of FIG. 1 anda syringe connectable to the one-way valve for withdrawing one or moredoses of the stored substance from the variable-volume storage chamberof the vial;

FIG. 4 is an enlarged, partial cross-sectional view of the upper portionof the multiple dose vial of FIG. 1 illustrating the one-way valve inthe first or normally-closed position, and an enlarged cross-sectionalview of the tip of a syringe prior to connection to the vial;

FIG. 5 is the same view as FIG. 4 but illustrating the female Luerconnector of the syringe placed into engagement with the male Luerconnector of the multiple dose vial;

FIG. 6 is the same view as FIGS. 4 and 5, but illustrating the femaleLuer connector of the syringe fully engaged with the male Luer connectorof the multiple dose vial, and the one-way valve in the second positionallowing one or more doses of the stored substance to be withdrawn fromthe storage chamber, through the one-way valve, and into the body of thesyringe;

FIG. 7 is an enlarged, partial cross-sectional view of the upper portionof a multiple dose vial, illustrating the one-way valve in the secondposition where the connector defines a tapered interior surface;

FIG. 8 is a perspective view of another embodiment of a multiple dosevial including a sliding seal received within the vial body, spacedrelative to the one-way valve, and defining the variable-volume storagechamber between the sliding seal and the one-way valve;

FIG. 9 is an exploded, perspective view of the vial body and the slidingseal of the multiple dose vial of FIG. 8;

FIG. 10 is a cross-sectional view of the multiple dose vial of FIG. 8with the sliding seal in an empty storage chamber;

FIG. 11 is an exploded, perspective view of another embodiment of amultiple dose vial including a flexible bladder received within the vialbody, and defining the variable-volume storage chamber between theflexible bladder wall and the side wall of the vial body;

FIG. 12A is a top perspective view of the multiple dose vial of FIG. 11,wherein the bladder is in a fully expanded state and the variable-volumestorage chamber is empty;

FIG. 12B is a top perspective view of multiple dose vial of FIG. 11,wherein the variable-volume storage chamber is partially filled and theflexible bladder is partially collapsed;

FIG. 13A is a side view of the multiple dose vial of FIG. 11, whereinthe flexible bladder is fully expanded and the variable-volume storagechamber is empty;

FIG. 13B is a side view of the multiple dose vial of FIG. 11, whereinthe variable-volume storage chamber is filled and the flexible bladderis collapsed;

FIG. 14 is a partial top perspective view of another embodiment of amultiple dose vial, wherein the body is a flexible and collapsible pouchincluding an inlet filling port and an outlet connector, and alsoshowing a flexible tube connectable to the connector for withdrawing oneor more doses of the stored substance from the variable-volume storagechamber of the pouch;

FIG. 15 is an enlarged partial top perspective view of the multiple dosevial of FIG. 14, illustrating the connector of the flexible tube fullyengaged with the connector of the multiple dose vial, allowing one ormore doses of the stored substance to be withdrawn from the storagechamber; and

FIG. 16 is a side view of the multiple dose vial of FIG. 14 in anupside-down position, such as for hanging, illustrating the connector ofthe flexible tube fully engaged with the connector of the multiple dosevial and a pump operatively connected to the tube for creating apressure differential greater than the valve opening pressure across theone-way valve.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In FIGS. 1-6, a device is indicated generally by the reference numeral10. In the illustrated embodiment, the device 10 is a multiple dosevial. However, as may be recognized by those of ordinary skill in thepertinent art based on the teachings herein, the invention is applicableto any of numerous other devices or methods that are currently known, orthat later become known. The vial 10 comprises a body 12 and a storagechamber 14 within the body for storing multiple doses of the substancetherein. In the illustrated embodiment, the storage chamber is avariable-volume storage chamber defined by a flexible and/or elasticpouch 16. A one-way valve 18 is connectable in fluid communication witha syringe 20 (FIGS. 3-6). The one-way valve 18 (i) permits substancefrom the storage chamber 14 to flow therethrough and into the syringe 20when connected in fluid communication therewith, and (ii) substantiallyprevents any fluid flow in a substantially opposite directiontherethrough and into the storage chamber 14 to thereby maintain thesubstance sterile, aseptic and/or contamination free.

The body 12 defines a side wall 22 (here cylindrical but can be anothershape), an opening 24 at the base of the side wall, and an upper wall 26enclosing the body 12 at the opposite end of the base. The upper wall 26defines a filling port 28 extending through a central region thereof,and a connector 30 including a male Luer connector 32 formed on theouter end thereof, an approximately dome-shaped base 34 extendingbetween the male Luer connector 32 and the upper wall 26, and a valveopening 36 extending through the connector for receiving the one-wayvalve 18.

As shown best in FIGS. 2A and 2B, the vial 10 includes a variable-volumestorage chamber, closure and one-way valve preassembly 38 that isreceived within and fixedly secured to the vial body 12 to form themultiple dose vial. The preassembly 38 comprises a closure 40 includinga relatively rigid closure base 42 and a relatively flexible closureoverlay 44 mounted on the closure base 42. The flexible closure overlay44 defines a flexible base and sealing member 46, a penetrable fillingportion or septum 48, a valve cover or member 50 of the one-way valve18, and an approximately dome-shaped spring 52 extending between thevalve member 50 and flexible base 46. As can be seen, when thepreassembly 38 is assembled to the vial body 12, the valve cover 50 isreceived within the valve opening 36 of the connector 30, and thedome-shaped spring 52 is received within the dome-shaped base 34 of theconnector 30.

As shown in FIGS. 2A and 3-6, the closure base 42 defines a fillinginlet 54 that is aligned, e.g., axially, with the filling port 28 of thevial body 12 and opens into the variable- volume storage chamber 14 ofthe flexible pouch 16. As can be seen, the flexible pouch 16 and fillinginlet 54 are integrally formed with the closure base 42. In theillustrated embodiment, the closure base 42, filling inlet 54, and apreform (not shown) for the flexible pouch 16 are injection molded, andthe pouch 16 is, in turn, blow molded from the injection molded preform,in accordance with the teachings of any of the following co-pendingpatent applications, each of which is hereby expressly incorporated byreference in its entirety as part of the present disclosure: U.S. patentapplication Ser. No. 12/577,126, filed Oct. 9, 2009, entitled “Devicewith Co-Extruded Body and Flexible Inner Bladder and Related Apparatusand Method,” which claims the benefit of similarly titled U.S.Provisional Application No. 61/104,613, filed Oct. 10, 2008; and U.S.patent application Ser. No. 12/901,420, filed Oct. 8, 2010, entitled“Device with Co-Molded Closure, One Way Valve and Variable-VolumeStorage Chamber, and Related Method,” which claims the benefit ofsimilarly titled U.S. Provisional Application No. 61/250,363, filed Oct.9, 2009.

As shown in FIG. 2A, the closure base 42 defines a circular-shapedrecess 56 that receives therein the flexible base and sealing member 46of the closure overlay 44. The closure base 42 further defines anannular seal channel 58 spaced radially inwardly relative to theperiphery of the circular-shaped recess 56. The flexible closure overlay44 defines a corresponding peripheral seal 60 and an annular seal 62spaced radially inwardly relative to the peripheral seal 60 andprojecting axially therefrom. The annular seal 62 of the closure overlay44 is received within the annular seal channel 58 of the closure base 42to form a fluid-tight seal therebetween, and the peripheral seal 60 ofthe closure overlay 44 is received within the periphery of the recess 56of the closure base 42 to form a fluid-tight seal therebetween. Theclosure base 42 further defines within the circular-shaped recess 56 avalve-receiving recess 64 aligned with the one-way valve 18, and afluid-flow channel 66 extending between the storage chamber port 54 andthe valve-receiving recess 64. As described further below, when thesyringe 20 is fully connected to the connector 30, the one-way valve 18is moveable from a first normally-closed position (FIG. 5) to a secondposition (FIG. 6) which, in turn, allows fluid to be withdrawn by thesyringe 20 from the variable-volume storage chamber 14, through thestorage chamber port 54, fluid flow channel 66, and one-way valve 18and, in turn, into the syringe 20. As shown best in FIGS. 4-6, the vialbody 12 defines a snap-fit protuberance 68 that is axially spacedadjacent to the upper wall 26 and extends annularly about the vial body.As can be seen, the side of the protuberance 68 opposite the upper wall26 is tapered inwardly to allow the closure 40 to slide past theprotuberance and into the assembled position as shown. The protuberance68 engages the underside of the closure base 42 to form a compressionseal between peripheral seal 60 and annular seal 62 of the flexibleoverlay 44 and the closure base 42, hermetically seal thevariable-volume storage chamber 14 with respect to ambient atmosphere,and fixedly secure the closure base 42 and thus the preassembly 38within the vial body 12. As should be understood by those of ordinaryskill in the pertinent art, the components of the vial may take any ofnumerous different shapes and/or configurations capable of performingthe function(s) of each such component as described herein.

The septum 48 is penetrable by a needle, filling or injection member(not shown) for sterile or aseptically filling the storage chamber 14with multiple doses of the substance to be dispensed. The septum 48, insome embodiments, is formed of a material that is sufficiently elasticto close itself after withdrawal of the needle, filling or injectionmember therefrom to thereby ensure that the head loss left by a residualpenetration hole after the injection member is withdrawn prevents fluidingress therethrough. Although such a septum 48 is self-closing, theseptum may be resealed by a liquid sealant such as silicone or asilicone-based sealant, and/or the application of radiation or energythereto to hermetically seal the substance within the storage chamber 14from the ambient atmosphere and thereby maintain the sterility of thesubstance.

For example, the septum 48 may be penetrable for sterile filling thevariable-volume storage chamber 14 and resealable, such as by theapplication of laser, other radiation, or thermal energy, tohermetically seal the filled substance within the storage chamber 14 inaccordance with the teachings of any of the following patents and patentapplications, each of which is hereby expressly incorporated byreference in its entirety as part of the present disclosure: U.S. patentapplication Ser. No. 12/254,789, filed Oct. 20, 2008, entitled“Container Having a Closure and Removable Resealable Stopper for Sealinga Substance Therein and Related Method,” which, in turn, claims thebenefit of U.S. patent application Ser. No. 60/981,107, filed Oct. 18,2007, entitled “Container Having a Closure and Removable ResealableStopper for Sealing a Substance Therein;” U.S. patent application Ser.No. 12/245,678, filed Oct. 3, 2008, entitled “Apparatus For Formulatingand Aseptically Filling Liquid Products,” and U.S. patent applicationSer. No. 12/245,681, filed Oct. 3, 2008, entitled “Method ForFormulating and Aseptically Filling Liquid Products,” which, in turn,claim the benefit of U.S. patent application Ser. No. 60/997,675, filedOct. 4, 2007, entitled “Apparatus and Method for Formulating andAseptically Filling Liquid Products;” U.S. patent application Ser. No.12/875,440, filed Sep. 3, 2010, entitled “Device with Needle Penetrableand Laser Resealable Portion and Related Method,” now U.S. Pat. No.7,980,276, which is a divisional of U.S. patent application Ser. No.12/371,386, filed Feb. 13, 2009, entitled “Device with Needle Penetrableand Laser Resealable Portion,” now U.S. Pat. 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No. 8,096,333, which is a continuation ofsimilarly titled U.S. patent application Ser. No. 10/983,178, filed Nov.5, 2004, now U.S. Pat. No. 7,628,184, which, in turn, claims the benefitof U.S. Provisional Patent Application No. 60/518,267, filed Nov. 7,2003, entitled “Needle Filling and Laser Sealing Station,” and similarlytitled U.S. Provisional Patent Application No. 60/518,685, filed Nov.10, 2003; U.S. patent application Ser. No. 11/901,467, filed Sep. 17,2007 entitled “Apparatus and Method for Needle Filling and LaserResealing,” which is a continuation of similarly titled U.S. patentapplication Ser. No. 11/510,961 filed Aug. 28, 2006, now U.S. Pat. No.7,270,158, which is a continuation of similarly titled U.S. patentapplication Ser. No. 11/070,440, filed Mar. 2, 2005; now U.S. Pat. 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No.8,112,972, which is a continuation of similarly titled U.S. patentapplication Ser. No. 11/074,454, filed Mar. 7, 2005, now U.S. Pat. No.7,669,390; U.S. patent application Ser. No. 11/339,966, filed Jan. 25,2006, entitled “Container Closure With Overlying Needle Penetrable andThermally Resealable Portion and Underlying Portion Compatible With FatContaining Liquid Product, and Related Method,” now U.S. Pat. No.7,954,521, which, in turn, claims the benefit of U.S. Provisional PatentApplication No. 60/647,049, filed Jan. 25, 2005, entitled “Containerwith Needle Penetrable and Thermally Resealable Stopper, Snap-Ring, andCap for Securing Stopper;” U.S. patent application Ser. No. 12/861,354,filed Aug. 23, 2010, entitled “Ready To Drink Container With Nipple andNeedle Penetrable and Laser Resealable Portion, and Related Method;”which is a divisional of similarly titled U.S. patent application Ser.No. 11/786,206, filed Apr. 10, 2007, now U.S. Pat. No. 7,780,023, which,into turn, claims the benefit of similarly titled U.S. ProvisionalPatent Application No. 60/790,684, filed Apr. 10, 2006; U.S. patentapplication Ser. No. 11/295,251, filed Dec. 5, 2005, entitled “One-WayValve, Apparatus and Method of Using the Valve,” now U.S. Pat. No.7,322,491, which, in turn, claims the benefit of similarly titled U.S.Provisional Patent Application No. 60/644,130, filed Jan. 14, 2005, andsimilarly titled U.S. Provisional Patent Application No. 60/633,332,filed Dec. 4, 2004; U.S. patent application Ser. No. 12/789,565, filedMay 28, 2010, entitled “Resealable Containers and Methods of Making,Filling and Resealing the Same,” which is a continuation of U.S. patentapplication Ser. No. 11/933,272, filed Oct. 31, 2007, entitled“Resealable Containers and Assemblies for Filling and Resealing Same,”now U.S. Pat. No. 7,726,357, which is a continuation of U.S. patentapplication Ser. No. 11/515,162, filed Sep. 1, 2006, entitled “SealedContainers and Methods of Making and Filling Same,” now U.S. Patent No.7,726,352; U.S. patent application Ser. No. 13/045,655, filed Mar. 11,2011, entitled “Sterile Filling Machine Having Filling Station andE-Beam Chamber,” which is a continuation of U.S. patent application Ser.No. 12/496,985, filed Jul. 2, 2009, entitled “Sterile Filling MachineHaving Needle Filling Station and Conveyor,” now U.S. Pat. No.7,905,257, which is a continuation of U.S. patent application Ser. No.11/527,775, filed Sep. 25, 2006, entitled “Sterile Filling MachineHaving Needle Filling Station within E-Beam Chamber,” now U.S. Pat. No.7,556,066, which is a continuation of similarly titled U.S. patentapplication Ser. No. 11/103,803, filed Apr. 11, 2005, now U.S. Pat. No.7,111,649, which is a continuation of similarly titled U.S. patentapplication Ser. No. 10/600,525, filed Jun. 19, 2003, now U.S. Pat. No.6,929,040, which, in turn, claims the benefit of similarly-titled U.S.Provisional Patent Application No. 60/390,212, filed Jun. 19, 2002; U.S.patent application Ser. No. 13/326,177, filed Dec. 14, 2011, entitled“Device with Penetrable and Resealable Portion and Related Method,”which is a continuation of similarly titled U.S. patent application Ser.No. 13/170,613, filed Jun. 28, 2011, now U.S. Pat. No. 8,347,923, whichis a continuation of U.S. patent application Ser. No. 12/401,567, filedMar. 10, 2009, entitled “Device with Needle Penetrable and LaserResealable Portion and Related Method,” now U.S. Pat. No. 7,967,034,which is a continuation of similarly titled U.S. patent application Ser.No. 11/933,300, filed Oct. 31, 2007, now U.S. Pat. No. 7,500,498; U.S.patent application Ser. No. 13/329,483, filed Apr. 30, 2011, entitled“Ready to Feed Container,” which is a continuation of InternationalApplication No. PCT/US2011/034703, filed Apr. 30, 2011, entitled “Readyto Feed Container and Method,” which, in turn, claims the benefit ofU.S. Provisional Patent Application No. 61/330,263 filed Apr. 30, 2010;and U.S. Provisional Patent Application No. 61/476,523, filed Apr. 18,2011, entitled “Filling Needle and Method.”

Alternatively, the septum 48 may be penetrable for sterile filling thevariable-volume storage chamber 14 and resealable with a liquid sealant,such as a silicone sealant, to hermetically seal the filled substancewithin the storage chamber 14, in accordance with the teachings of anyof the following patent applications, each of which is hereby expresslyincorporated by reference in its entirety as part of the presentdisclosure: U.S. patent application Ser. No. 12/577,126, filed Oct. 9,2009, entitled “Device with Co-Extruded Body and Flexible Inner Bladderand Related Apparatus and Method,” which claims the benefit of similarlytitled U.S. Provisional Patent Application No. 61/104,613, filed Oct.10, 2008; U.S. patent application Ser. No. 12/901,420, filed Oct. 8,2010, entitled “Device with Co-Molded One-Way Valve and Variable VolumeStorage Chamber and Related Method,” which claims the benefit ofsimilarly titled U.S. Provisional Patent Application No. 61/250,363,filed Oct. 9, 2009; and U.S. Provisional Patent Application No.61/476,523, filed Apr. 18, 2011, entitled “Filling Needle and Method.”

Prior to filling the variable-volume storage chamber 14, the sealedempty chamber may be sterilized by injecting a fluid sterilant therein,such as nitric oxide, with a needle, filling, or injection memberthrough the penetrable and resealable portion 48, and the needleemployed for injecting the fluid sterilant and/or the substance to besterile filled into the variable-volume storage chamber 14 may be aself-opening and closing needle, in accordance with the teachings of anyof the following co-pending patent applications, each of which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure: U.S. patent application Ser. No. 13/450,306, filedApr. 18, 2012, entitled “Needle with Closure and Method,” which claimsthe benefit of U.S. Provisional Patent Application No. 61/476,523, filedApr. 18, 2011, entitled “Filling Needle and Method;” and U.S. patentapplication Ser. No. 13/529,951, filed Jun. 21, 2012, entitled “FluidSterilant Injection Sterilization Device and Method,” which claims thebenefit of U.S. Provisional Patent Application No. 61/499,626, filedJun. 21, 2011, entitled “Nitric Oxide Injection Sterilization Device andMethod.” As may be recognized by those of ordinary skill in thepertinent art based on the teachings herein, the penetrable andresealable portion or septum may be penetrated and resealed, and thevariable-volume storage chamber may be sterilized and sterile filled, byany of numerous different devices and methods that are currently known,or that later become known.

As shown best in FIGS. 4-6, the one-way valve 18 includes a relativelyrigid valve seat 70 that is received within the flexible valve member orcover 50 and defines a normally closed, valve seam 72 therebetween. Inthe illustrated embodiment the valve seam 72 is axially-elongated andannular, but can have other shapes and configurations. The valve member50 engages, and in some embodiments forms an interference fit with, thevalve seat 70 to thereby form a fluid-tight seal in the normally closedposition and, in turn, maintain the substance within the storage chamber14 in a sterile and hermetically sealed condition. The valve 18 definesa valve opening pressure and remains in the normally closed positionunless a pressure differential across the valve exceeds the valveopening pressure. When a pressure differential across the valve doesexceed the valve opening pressure, the valve member 50 expands, e.g.,radially, relative to or otherwise moves away from the valve seat 70 andopens the valve seam 72 therebetween.

The valve opening pressure is defined, in part, as a function of thelength of the engagement of the valve member 50 with the valve seat 70,i.e., the axial extent of the valve seam 72. The greater the lengththereof, the greater the valve opening pressure. As shown, the valveseat 70 defines at least one elongated groove 71 therein. Thus, thevalve member 50 need not be displaced at the groove(s) 71 for the fluidto flow. Accordingly, the length, and number, of the groove(s) 71effectively reduces the length of the valve seam 72 and thus effectivelyreduces the valve opening pressure of the valve 18. The length andnumber of the groove(s) 71 are configured, in consideration of theproperties of the valve member 50, e.g., its elasticity, thickness,shape, etc., such that a delivery device engaging the valve 18 andutilized in a normal manner, e.g., withdrawing a plunger from a barrelof a syringe engaging the valve, is capable of creating a pressuredifferential across the valve that exceeds the valve opening pressure,and this opens the valve seam 72. Conversely, these features areconfigured to maintain a minimum valve opening pressure to preventunintentional opening, as should be understood by one of ordinary skillin the pertinent art.

In some embodiments, such as seen in FIGS. 7 and 10, the valve member50′, 150 may also define a substantially tapered cross-sectional shapemoving in the direction from an inlet towards an outlet of the valve.This configuration requires progressively less energy to open the valvewhen moving from the interior, or inlet, toward the exterior, or outlet,of the valve. Alternatively, or in combination with the tapered valvemember 50′, 150, the valve seat 70′, 170 may define an outer diameterthat progressively or otherwise increases in the direction from theinlet towards the outlet of the valve, to provide the same or similareffect. As a result, once the pressure is sufficient to open the valveat an inlet thereof, the pressure is sufficient to cause the downstreamsegments or portions of the valve member 50′, 150 to progressively openand then close after passage of substance through the respective portionof the valve seam 72′, 172 when moving in the direction from the inlettowards the outlet of the valve to dispense the dosage of substance.Also, in some embodiments, at any time when dispensing a dosage ofsubstance, at least one of the plurality of segments of the valve member50 engages the valve seat 70 to maintain a fluid-tight seal across thevalve 18, and thereby prevent ingress of fluid, germs, bacteria or otherunwanted substances therethrough and into the variable-volume storagechamber 14.

As indicated above, the valve 18 includes a substantially dome-shapedspring 52 formed of a resilient and/or elastomeric material. The spring52 permits the valve member 18 to move between an extended firstposition (FIG. 5), wherein the valve member 50 is fully received withinthe valve opening 36 of the connector, and a depressed second position(FIG. 6) wherein the valve member 50 is depressed or otherwise moveddistally within the valve opening 36 and out of engagement with theinterior surface 74 of the connector 30. As can be seen, the dome-shapedspring 52 normally biases the valve 18 in the direction from the secondposition toward the first position. The spring 52 also substantiallyprevents pressure created by inadvertently ejected air or other materialfrom a syringe or other delivery device 20 connected to the valve 18from moving the valve from the first position toward the secondposition.

When in the first position (FIG. 5), the interior surface 74 forming thevalve opening 36 engages the valve member 50 or otherwise substantiallyprevents expansion or opening of the valve member 50 relative to thevalve seat 70, and thus prevents the valve 18 from opening. The valveseam 72 is closed, thereby preventing the passage of the substancetherethrough. When in the second position (FIG. 6), on the other hand,the valve member 50 is disengaged from the interior surface 74 withsufficient space around it so that the valve 18 is free to open (andopen the valve seam 72) when a pressure differential across the valve 18exceeds the valve opening pressure to, in turn, permit expansion of thevalve member 50 relative to the valve seat 70 and thereby allow the flowof substance from the variable-volume storage chamber therethrough.

The flexible valve member 50 defines a base portion 76 that engages adistal base of the valve seat 70 to support the valve seat, e.g.,axially, within the valve 18. The base portion 76 defines one or morevalve inlet apertures 78 therethrough, in fluid communication with thenormally closed valve seam 72, to permit fluid flow from thevariable-volume storage chamber 14 and through the valve seam 72, whenthe valve 18 is in the second position and the pressure differentialacross the valve exceeds the valve opening pressure. The outlet end ofthe valve seat 70 defines a plurality of angularly spaced protuberances79 thereon that engage a syringe connector 84 of the syringe 20 andpermit the flow of fluid therebetween (between the protuberances 79) inorder to allow fluid flow through the valve 18 and into the syringe 20.

In order to dispense the substance from the vial 10, the syringe orother delivery device 20 is connected to the connector 30. As shown inFIG. 3, the syringe 20 includes a barrel 80, a manually-engageableplunger 82 received within the barrel, and the connector 84 mounted atone end of the barrel and in fluid communication with the interior ofthe barrel. In the illustrated embodiment, the vial connector 30 is amale Luer connector, and the syringe connector 84 is a female Luerconnector. However, as may be recognized by those of ordinary skill inthe pertinent art based on the teachings herein, any of numerousdifferent connectors for either the syringe or other delivery device, orthe multiple dose vial or other device, that are currently known, orthat later become known, may be used.

When connected to the vial 10, as shown, for example, in FIGS. 5 and 6,the connector 84 of the syringe 20 engages the valve seat 70 anddisplaces the valve 18 from the first position toward the secondposition. When in the second position, the connector 30 and the valve 18define a cavity 75 therebetween. Thus, if the plunger 82 of the syringe20 is mistakenly depressed further into barrel of the syringe 20,thereby ejecting air (or other substances) therefrom, the valve 18remains closed and the ejected material does not flow therethrough, butrather enters into the cavity 75 surrounding the valve 18. The pressureof the air in the cavity 75 functions to further compress the flexiblevalve member 50 onto the valve seat 70, i.e., helping to keep the valve18 closed, thereby further ensuring no entry of material through thevalve 18 and into the storage chamber 14. In some embodiments, such asshown in FIG. 7, the interior surface 74′ of the connector 30′ defines asubstantially tapered cross-sectional shape moving in the direction fromthe dome shaped base 34′ toward the Luer connector 32′, therebyrequiring relatively less movement (compared to embodiments where theinterior surface 74′ is not tapered) of the valve 18′ in the directionfrom the first position toward the section position in order todisengage the interior surface 74′ from the valve member 50′. Thus, thecavity 75′ is larger in or to accommodate a greater volume ofinadvertently ejected air, and further compress the valve 18′. The taperis also sufficient so that the valve member 50′ can move away from thevalve seat 70′ and open the valve 18′.

Conversely, when in the second position and upon withdrawal of theplunger 82 of the syringe 20, a vacuum or partial vacuum is createdwithin the barrel of the syringe 20 which, in turn, creates a pressuredifferential across the valve 18. When the pressure differential acrossthe valve 18 exceeds the valve opening pressure, the valve seam 72opens, and the substance within the variable-volume storage chamber 14flows through the valve inlet aperture(s) 78 and, in turn, through thevalve seam 72 and into the barrel of the syringe. Because the valve 18is in the second position, the valve member 50 is permitted to moverelative to the valve seat 70, e.g., radially, to allow the flow of thesubstance from the variable-volume storage chamber therethrough and intothe syringe. However, because of the nature of the valve member 50, anyambient air or other fluid that could contaminate the interior of thevalve or storage chamber is substantially prevented from flowing throughthe valve in the opposite direction, as discussed above. As a result,the interior of the valve and storage chamber can be maintained sterile,aseptic, and/or contamination free, as desired, throughout dispensing ofdosages from the storage chamber. When withdrawal of the syringe plunger82 is terminated, the pressure differential, if any, across the valve 18decreases to than the valve opening pressure, the valve seam 72 closes(the valve member 50 moves back into engagement with the valve seat 70)and the flow of substance from the variable-volume storage chamber 14through the valve 18 is terminated.

Upon disconnection, e.g., unscrewing, of the syringe connector 84 fromthe vial connector 30, the dome-shaped spring 52 drives the valve fromthe second position toward the first position where the interior surface74 of the connector engages the valve member 50 and further prevents thepossibility of the valve seam 72 opening and any fluid flow through thevalve. In embodiments as in FIG. 7 where the interior surface 74′ istapered, the taper assists in guiding the valve 18 into the firstposition. Thus, the valve 18 permits substance from the variable-volumestorage chamber 14 to flow through the one-way valve and into thedelivery device connected in fluid communication therewith, but preventsthe ingress of fluid in a substantially opposite direction into thevariable-volume storage chamber. Consequently, the substance within thevariable-volume storage chamber 14 is never exposed to the ambientatmosphere. When another dose of substance is needed from the vial, thesame steps may be repeated.

In FIGS. 8-10, another device is indicated generally by the referencenumeral 110. The device 110 is substantially similar to the devices 10,10′ described above in connection with FIGS. 1-7, and therefore likereference numerals preceded by the numeral “1” are used to indicate likeelements. A primary difference of the device 110 in comparison to thedevice 10 is that a sliding seal or stopper 186 is received within thevial body 112 and is spaced relative to the one-way valve 118, whereinthe variable-volume storage chamber 114 is defined between the slidingseal 186 and the one-way valve 118, as hereinafter described.

The sliding seal 186 includes at least one, and in the embodiment shown,best seen in FIG. 9, two axially spaced outer annular sealing members orportions 187 that sealingly engage the interior cylindrical wall of thevial body 112 to form a fluid-tight seal therebetween, but permit thesliding stopper to slide within the vial body. The sealing members orportions 187 may be formed integral with the sliding seal 186, such asby forming thereon annular protuberances, as shown, or may be formed bysealing members, such as o-rings or other sealing members, that arereceived within corresponding grooves or recesses formed in the slidingseal. A removable base closure 188 encloses the opening 124 at the baseof the vial body 112, and includes one or more vent apertures 189 toprevent the formation of a vacuum between the sliding seal 186 and thebase closure 188, and otherwise to allow the sliding seal 186 to travelthrough the vial body 112 upon dispensing of the substance from the vial110, as described further below.

The sliding seal 186 and the manner in which it cooperates with the vialbody 112 to define the variable-volume storage chamber 114 may be thesame as or substantially similar to that disclosed in any of thefollowing patents and patent applications, each of which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure: U.S. patent application Ser. No. 13/219,597, filedAug. 26, 2011, entitled “Laterally-Actuated Dispenser with One-Way ValveFor Storing and Dispensing Substances,” which is a continuation of U.S.patent application Ser. No. 12/710,516, filed Feb. 23, 2010, entitled“Laterally-Actuated Dispenser with One-Way Valve for Storing andDispensing Metered Amounts of Substances,” now U.S. Pat. No. 8,007,193,which is a continuation of similarly titled U.S. patent application Ser.No. 11/237,599, filed Sep. 27, 2005, now U.S. Pat. No. 7,665,923, which,in turn, claims the benefit of similarly titled U.S. Provisional PatentApplication No. 60/613,583, filed Sep. 27, 2004, and similarly titledU.S. Provisional Application No. 60/699,607 filed Jul. 15, 2005; andU.S. patent application Ser. No. 13/743,661, filed Jan. 17, 2013,entitled “Multiple Dose Syringe and Method,” which, in turn, claims thebenefit of similarly titled U.S. Provisional Patent Application No.61/587,500, filed Jan. 17, 2012.

In the illustrated embodiment, the closure 140, including the closurebase 142, is integrally formed with the upper side of the vial body 112,and the flexible closure overlay 144 is mounted thereon in the samemanner as in the embodiments described above in connection with FIGS.1-7. A vial cap 127, defining the upper wall 126 and connector 130,mounts atop the closure overlay 144 to sealingly enclose the body 112 atthe upper side of the vial 110. The vial cap 127 further defines thesnap-fit protuberance 168 that is axially spaced adjacent to the upperwall 126 and extends annularly about the cap 127. The side of theprotuberance 168 opposite the upper wall 126 is tapered inwardly toallow the closure base 142 of the vial body 112 to slide over theprotuberance and snap into the assembled position as shown. Theprotuberance 168 engages the underside of the closure base 142 to form acompression seal between the peripheral seal 160 and annular seal 162 ofthe flexible overlay 144 and the closure base 142, hermetically seal thevariable-volume storage chamber with respect to the ambient atmosphere,and fixedly secure the vial cap 127 onto the vial body 112.

In the illustrated embodiment, the flexible closure overlay 144 definesthe flexible base and sealing member 146, the penetrable and resealableportion or septum 148, the valve cover or member 150 of the one-wayvalve 118, and the approximately dome-shaped spring 152. The closurebase 142 defines, within the circular-shaped recess 156, thevalve-receiving recess 164 aligned, e.g., axially, with the one-wayvalve 118, and at least one fluid-flow aperture 190 within thevalve-receiving recess 164.

Similar to the embodiments described above in connection with FIGS. 1-7,the penetrable and resealable portion or septum 148 is penetrable by aneedle, filling or injection member (not shown) for sterile oraseptically filling the storage chamber 114 with multiple doses of thesubstance to be dispensed. The septum 148, can be formed of a materialthat is sufficiently elastic to close itself after withdrawal of theneedle, filling or injection member therefrom to thereby ensure that thehead loss left by a residual penetration hole after the injection memberis withdrawn prevents fluid ingress therethrough. Although such a septum148 is self-closing, the septum may be resealed by a liquid sealant,such as silicone or a silicone-based sealant, and/or the application ofradiation or energy thereto to hermetically seal the substance withinthe storage chamber 114 from the ambient atmosphere and thereby maintainthe sterility of the substance. The septum 148 may be penetrable forsterile filling the variable-volume storage chamber and resealable, suchas by the application of laser, other radiation, or thermal energy, tohermetically seal the filled substance within the storage chamber inaccordance with the teachings of any of the patents and patentapplications incorporated by reference above. Alternatively, the septum148 may be penetrable for sterile filling the variable-volume storagechamber, and resealable with a liquid sealant, such as a siliconesealant, to hermetically seal the filled substance within the storagechamber, in accordance with the teachings of any of the patents andpatent applications incorporated by reference above.

Prior to filling the variable-volume storage chamber, the sealed emptychamber may be sterilized by injecting a fluid sterilant therein, suchas nitric oxide, with a needle, filling or injection member through thepenetrable and resealable portion 148, and the needle employed forinjecting the fluid sterilant and/or the substance to be sterile filledinto the variable-volume storage chamber may be a self opening andclosing needle, in accordance with the teachings of any of the patentsand patent applications incorporated by reference above.

Similar to the embodiments described above, the one-way valve 118includes a relatively rigid valve seat 170 that is received within theflexible valve member or cover 150 and defines a normally closed, valveseam 172 therebetween. The valve member 150 engages, and in alternativeembodiments forms an interference fit with, the valve seat 170 tothereby form a fluid-tight seal in the normally closed position and, inturn, maintain the substance within the storage chamber 114 in a sterileand hermetically sealed condition. The valve 118 defines a valve openingpressure, and remains in the normally closed position unless a pressuredifferential across the valve exceeds the valve opening pressure. When apressure differential across the valve does exceed the valve openingpressure, the valve member 150 expands, e.g., radially, relative to orotherwise moves away from the valve seat 170 and opens the valve seam172 therebetween.

The valve 118 includes a substantially dome-shaped spring 152 formed ofa resilient and/or elastomeric material. Similar to the embodimentdescribed above, the spring 152 permits the valve member 118 to movebetween an extended first position wherein the valve member 150 is fullyreceived within the valve opening 136 of the connector 130, and adepressed second position wherein the valve member 150 is depressed orotherwise moved distally within the valve opening 136 and out ofengagement with the connector 130. As can be seen, the dome-shapedspring 152 normally biases the valve 118 in the direction from thesecond position toward the first position.

When in the first position, the interior surface 174 forming the valveopening 136 engages the valve member 150 or otherwise substantiallyprevents radial expansion or opening of the valve member 150 relative tothe valve seat 170, and thus prevents the valve 118 from opening. Theannular valve seam 172 is closed. When in the second position, the valvemember 150 is disengaged from the connector interior surface 174 withsufficient space around it so that the valve 118 is free to open (andopen the valve seam 172) when a pressure differential across the valve118 exceeds the valve opening pressure to, in turn, permit expansion ofthe valve member 150 relative to the valve seat 170 and thereby allowthe flow of substance from the variable-volume storage chambertherethrough.

The flexible valve member 150 defines a base portion 176 that engages aninner end of the valve seat 170 to support the valve seat within thevalve 118. The base portion 176 defines one or more valve inletapertures 178 therethrough in fluid communication with the normallyclosed annular valve seam 172 to permit fluid flow from thevariable-volume storage chamber 114 through the valve 118 when in thesecond position and the pressure differential across the valve exceedsthe valve opening pressure. The outlet end of the valve seat 170 definesa plurality of angularly spaced protuberances 179 thereon that engage asyringe connector 84 of the syringe 20 but permit the flow of fluidtherebetween (between the protuberances 179) in order to allow fluidflow through the valve 118 and into the syringe 20.

In order to dispense the substance from the vial, the syringe or otherdelivery device 20 is connected to the connector 130. When connected tothe vial 110, the connector 84 of the syringe engages the valve seat 170and displaces the valve 118 from the first position to the secondposition. When in the second position, and upon withdrawal of theplunger 82 of the syringe, a vacuum or partial vacuum is created withinthe barrel of the syringe 20 which, in turn, creates a pressuredifferential across the valve 118. When the pressure differential acrossthe valve 118 exceeds the valve opening pressure, the valve seam 172opens and the substance within the variable-volume storage chamber flowsthrough the fluid flow aperture(s) 190 and subsequently through thevalve inlet aperture(s) 178 and, in turn, through the valve seam 172 andinto the barrel of the syringe 20. As substance is dispensed from thevariable-volume storage chamber 114, suction forces exerted on thesliding seal 186 caused by the exit of the substance from the storagechamber 114 cause the seal to move or slide within the vial body 112toward the one-way valve 118 to reduce the volume of the variable-volumestorage chamber 114 by substantially the same volume of substancedispensed.

When withdrawal of the syringe plunger 82 is terminated, the pressuredifferential, if any, across the valve 118 decreases to less than thevalve opening pressure, and the flow of substance from thevariable-volume storage chamber 114 through the valve 118 is terminated.Upon disconnection of the syringe connector 84 from the vial connector130, the dome-shaped spring 152 drives the valve from the secondposition toward the first position where the interior surface 174 of theconnector engages the valve member 150 and further prevents thepossibility of any fluid flow through the valve. When another dose ofsubstance is needed from the vial, the same steps may be repeated. Thus,the interior of the valve and storage chamber can be maintained sterile,aseptic, and/or contamination free, as desired, throughout dispensing ofdosages from the storage chamber, as explained in the embodimentdescribed above.

In FIGS. 11-13B, another embodiment of the device is indicated generallyby the reference numeral 210. The device 210 is substantially similar tothe devices 10, 10′ and 110 described above in connection with FIGS.8-10, and therefore like reference numerals preceded by the numeral “2”are used to indicate like elements. For simplicity, the followingdescription is directed to the differences in the variable-volumestorage chamber 214 within the vial body 212.

As shown in the illustrated embodiment of FIG. 11, the vial 210 includesa collapsible flexible bladder 291 integrally formed with, andprojecting from, a base closure 288. The base closure 288 sealinglyencloses the base of the vial body 212, thereby sealing off the storagechamber 214 from the ambient atmosphere, and the flexible bladder 291projects within the vial body 212 toward the opposing valve end of thevial 210. Alternatively, in other embodiments, the bladder 291 mayextend from the closure 240 toward the base end of the vial 210. Thevariable-volume storage chamber 214 is defined between the flexiblebladder 291 and the side wall 222 of the vial body 212. The flexiblebladder 291 has a bladder wall 292 defining a bladder cavity 293therein. The flexible bladder 291 has a substantially central opening294 at a base end thereof, defining an open port 295 in the base closure288 in fluid communication with the bladder cavity 293.

In the illustrated embodiment, the base closure 288 and a preform (notshown) for the flexible bladder 291 are injection molded, and thebladder 291 is, in turn, blow molded from the injection molded preform,in accordance with the teachings of any of the patents and patentapplications incorporated by reference above. In other embodiments, theelastic bladder 291 is sealed and is compressible and expandable.

The flexible bladder 291 is tubular in configuration and defines anexternal diameter dimensioned to fit within the vial body 212 when inthe fully expanded state as shown in FIGS. 12A and 13A. However, thebladder 291 can have other configurations capable of performing thefunctions of the bladder as described herein. In the fully expandedstate, as shown in FIGS. 11, 12A, 13A, the wall 292 of the bladder 291defines a shape or morphology substantially the same as that of the vialbody side wall 222 so that it conforms to and contacts the vial bodyside wall 222 throughout the interface of these two components. In thisstate, the empty variable- volume storage chamber is substantiallyairless.

The storage chamber 214 is sterile or aseptically filled with multipledoses of the substance to be dispensed via the penetrable and resealableportion or septum 248, in similar manner as in the embodiments describedabove. As the storage chamber 214 is filled with the substance, thebladder 291 collapses, as shown in FIGS. 12B and 13B and explainedfurther below. Thereafter, when the connector 84 of the syringe 20engages the valve seat 270, displaces the valve 218 from the firstposition to the second position, and the plunger 82 is subsequentlywithdrawn, the substance within the variable-volume storage chamber 214flows through the one-way valve 218 and into the barrel of the syringe20. As each dose of substance is dispensed from the variable-volumestorage chamber 214, the bladder 291 inflates accordingly, as alsoexplained further below. As shown in FIGS. 12A and 13A, the bladder 291is expandable until the bladder wall 292 substantially conforms to themorphology of the side wall 222 of the vial body 212, to therebyeliminate any ullage or dead space and dispense substantially all of thesubstance in the storage chamber 214.

The sealed interior of the vial body 212, comprised of thevariable-volume storage chamber 214 and the flexible bladder 291,defines a constant volume. As the volume of the storage chamber 214increases, the volume of the flexible bladder cavity 293 substantiallycorrespondingly decreases, and likewise, as the volume of the storagechamber 214 decreases, the volume of the flexible bladder cavity 293substantially correspondingly increases.

As shown in FIG. 11, the flexible bladder 291 is assembled into the vialbody 212 in its fully expanded state. Any air in the vial body 212 isthus displaced out the rear of the vial body 212 during assembly.Thereafter, when the sealed variable-volume storage chamber 214 isfilled with a desired volume of substance, i.e., when substance isfilled between the side wall 222 of the vial body 212 and the wall 292of the flexible bladder 291, the flexible bladder 291 collapsesaccordingly, where a substantially equal volume of air flows out of thebladder cavity 293, through the open port 295, and into the ambientatmosphere. Afterwards, when a dose of the substance within thevariable-volume storage chamber 214 is dispensed therefrom, through thevalve 218, the pressure differential between the variable-volume storagechamber 214 and the atmosphere causes a substantially equal volume ofair to flow into the bladder cavity 293, through the port 295, andre-expand the bladder. In some embodiments, a one-way valve is insertedinto the open port 295 of the base closure 288 after the variable-volumestorage chamber 214 is filled with the substance and the bladder 291 iscollapsed. The one-way valve allows air to flow into the bladder cavity293 with each dose of substance dispensed, but substantially preventsair from flowing out of the cavity. As may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, theone-way valve may take the form of any of numerous different one-wayvalves, that are currently known, or that later become known, forperforming the function of the one-way valve as described herein,including without limitation a check valve, a duckbill valve, a flappervalve or an umbrella valve.

In FIGS. 14-16, another device is indicated generally by the referencenumeral 310. The device 310 is substantially similar to the devices 10,10′, 110 and 210 described above in connection with FIGS. 1-13B, andtherefore like reference numerals preceded by the numeral “3” are usedto indicate like elements. A primary difference of the device 310 incomparison to the device 10 is that the body 312 is a collapsiblebladder, bag or pouch, rather than a rigid vial body 12, as hereinafterdescribed.

The collapsible pouch 312 defines the variable-volume storage chamber314 therein. As shown best in FIGS. 14 and 15, the collapsible pouch 312includes a filling port 328 and an outlet connector 330. In theillustrated embodiment, the filling port 328 and the connector 330 areboth located at one end of the pouch 312. However, as should berecognized by those of ordinary skill in the pertinent art, the fillingport and connector may equally be located at opposing ends of the pouch312. The filling port may also be on the pouch 312 itself. Similar tothe embodiments described above, the filling port 328 is utilized forsterile or aseptically filling the storage chamber 314 therethrough withmultiple doses of the substance to be dispensed, and the outletconnector 330 is utilized for dispensing doses of substance therefrom.With each dose of substance dispensed, the pouch 312 is collapsible byapproximately the same volume.

Similar to the above-described embodiments, the particular filling port328 shown includes a penetrable and resealable portion or septum 348.The septum 348 is penetrable by a needle, filling or injection member(not shown) for sterile or aseptically filling the storage chamber 314with multiple doses of the substance to be dispensed. The septum 348, insome embodiments, is formed of a material that is sufficiently elasticto close itself after withdrawal of the needle, filling or injectionmember therefrom to thereby ensure that the head loss left by a residualpenetration hole after the filling or injection member is withdrawnprevents liquid ingress therethrough. Like septums 48, 48′, 148, 248,although the septum 348 is sufficiently self-closing to prevent liquidpassage, the septum may be resealed by a liquid sealant, such assilicone or a silicone-based sealant, and/or the application ofradiation or energy thereto in order to hermetically seal the substancewithin the storage chamber 314 to prevent ingress of air or contaminantsfrom the ambient atmosphere or environment and thereby maintain thesterility thereof. The septum 348 may be penetrable for sterile fillingthe variable-volume storage chamber and resealable, such as by theapplication of radiation or energy, e.g., laser radiation or thermalenergy, to hermetically seal the filled substance within the storagechamber in accordance with the teachings of any of the patents andpatent applications incorporated by reference above. Alternatively, theseptum 348 may be penetrable for sterile filling the variable-volumestorage chamber 314, and resealable with a liquid sealant, such as asilicone sealant, to hermetically seal the filled substance within thestorage chamber, in accordance with the teachings of any of the patentsand patent applications incorporated by reference above.

The outlet connector 330 includes a one-way valve 318 therein, similarin design and function to the one way valves 18, 18′, 118, and 218 ofthe above-described embodiments, and a Luer connector 332 formed at theouter end thereof. The one-way valve 318 is connectable in fluidcommunication with a syringe or other delivery device 320 via the Luerconnector 332. As described above, the one-way valve 318 (i) permitssubstance from the storage chamber 314 to flow therethrough and into thedispensing member 320 when connected in fluid communication therewith,and (ii) substantially prevents any fluid flow in a substantiallyopposite direction therethrough and into the storage chamber 314 tothereby maintain the substance sterile, aseptic, and/or contaminationfree.

The illustrated delivery device 320 includes a flexible tube 380 havinga connector 384 at an inlet end thereof, and a pump 382 (FIG. 16)operatively associated with the tube 380. In order to dispense thesubstance from the storage chamber 314 of the pouch 312, the connector384 of the flexible tube 380 is connected to the pouch outlet connector330 (FIGS. 15, 16). In the illustrated embodiment, the Luer connector332 of the outlet connector 330 is a male Luer connector, and theflexible tube connector 384 is a female Luer connector. However, as maybe recognized by those of ordinary skill in the pertinent art based onthe teachings herein, any of numerous different connectors for eitherthe delivery device or the pouch that are currently known, or that laterbecome known, may be used.

When connected to the pouch 312, the connector 384 of the flexible tube380 displaces the valve 318 from the first position to the secondposition, similarly to as described above with respect to the previousembodiments. When in the second position, operation of the pump 382creates a pressure differential across the valve 318 exceeding the valveopening pressure, thereby opening the valve 318 and allowing thesubstance to flow from the storage chamber 314, through the valve 318,and through the tube 380.

Similar to as described above with respect to the previous embodiments,any ambient air or other fluid that could contaminate the interior ofthe valve 318 or storage chamber 314 is substantially prevented fromflowing through the valve in the opposite direction. As a result, theinterior of the valve and storage chamber can be maintained sterile,aseptic, and/or contamination free, as desired, throughout dispensing ofdosages from the storage chamber. When operation of the pump 382 isterminated, the pressure differential, if any, across the valve 318 isless than the valve opening pressure, and the flow of substance from thevariable-volume storage chamber 314 through the valve 318 is alsoterminated. Additionally, any substance within the flexible tube 380,between the valve 318 and the pump 382, is sealed by the pump 382, andprevented from flowing past it. As should be understood by those ofordinary skill in the pertinent art based on the teachings herein, anyof numerous different pumps or actuators, currently known or that laterbecome known, may be utilized with the flexible tube to draw fluid outof the storage chamber and through the one-way valve. For example, andwithout limitation, a peristaltic pump may be utilized. As anotherexample, a syringe can be connected to the end of the tube 380 towithdraw fluid from the pouch 312.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous changes and modifications may bemade to the above-described and other embodiments of the presentinvention without departing from its scope as defined in the claims. Forexample, the components of the vial may be made of any of numerousdifferent materials or combinations of materials that are currentlyknown, or that later become known for performing the function(s) of eachsuch component. Similarly, the components of the vial may take any ofnumerous different shapes and/or configurations, and may be manufacturedin accordance with any of numerous different methods or techniques thatare currently known, or later become known.

As another example, the penetrable and resealable portion may be locatedat a different part of the vial rather than the flexible closure overlayat the top end thereof. For example, and without limitation, inembodiments having a sliding seal or a flexible bladder formed with abase closure, the seal or the base closure may include the penetrableand resealable septum, respectively. In such a configuration, thevariable-volume storage chamber may be filled in like manner asdescribed above, but from the base end of a vial rather than from theopposing dispensing valve end. One advantage of such a configuration isthat a sliding seal or base closure and flexible bladder including apenetrable and resealable septum would define a universal bottom whichmay be utilized with any vial having an open end at one end and adispensing port and/or valve at the opposing end. Such a setup wouldrequire no modification to the vial. Rather, after assembling thesliding seal or base closure and flexible bladder in sealing engagementwith the vial, it would be aseptically fillable via the septum therein,and define a variable-volume storage chamber resulting from thefunctionality of the sliding seal or the flexible bladder.

Further, rather than sterile or aspect fill the storage chamber with apenetrable and resealable septum, as described above, the storagechamber may be sterile or aseptic filled through a non-piercing fillingcannula or probe that is connectable in fluid communication with aone-way valve mounted on the vial body or otherwise on the device, e.g.,on the sliding seal or base closure, in fluid communication with thestorage chamber. For example, the filling cannula and/or one-way valvemay be constructed in accordance with the teachings of any of thefollowing patents and patent applications, each of which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure: U.S. patent application Ser. No. 12/534,730, filedAug. 3, 2009, entitled “Lyophilization Method and Device,” now U.S. Pat.No. 8,272,411, which is a continuation of U.S. patent application Ser.No. 11/487,836, filed Jul. 17, 2006, entitled “Container with ValveAssembly and Apparatus and Method for Filling,” now U.S. Pat. No.7,568,509, which is a continuation of U.S. patent application Ser. No.10/833,371, filed Apr. 28, 2004, entitled “Container with Valve Assemblyfor Filling and Dispensing Substances, and Apparatus and Method forFilling,” now U.S. Pat. No. 7,077,176, which, in turn, claims thebenefit of similarly titled U.S. Provisional Patent Application No.60/465,992, filed Apr. 28, 2003, and U.S. Provisional Patent ApplicationNo. 60/469,677, filed May 12, 2003, entitled “Dispenser and Apparatusand Method for Filling a Dispenser,” and similarly titled U.S.Provisional Patent Application No. 60/471,592, filed May 19, 2003; U.S.patent application Ser. No. 12/984,482, filed Jan. 4, 2011, entitled“Dispenser and Apparatus and Method for Filling a Dispenser,” which is acontinuation of similarly titled U.S. patent application Ser. No.12/025,362, filed Feb. 4, 2008, now U.S. Pat. No. 7,861,750, which is acontinuation of similarly titled U.S. patent application Ser. No.11/349,873, filed Feb. 8, 2006, now U.S. Pat. No. 7,328,729, which is acontinuation of similarly-titled U.S. patent application Ser. No.10/843,902, filed May 12, 2004, now U.S. Pat. No. 6,997,219, which, inturn, claims the benefit of similarly titled U.S. Provisional PatentApplication No. 60/469,677, filed May 12, 2003, and similarly titledU.S. Provisional Patent Application No. 60/471,592, filed May 19, 2003,and U.S. Provisional Patent Application No. 60/488,355, filed Jul. 17,2003, entitled “Piston-Type Dispenser with One-Way Valve for Storing andDispensing Metered Amounts of Substances, and Pivoting Cover forCovering Dispensing Portion Thereof,” and U.S. Provisional PatentApplication No. 60/539,814, filed Jan. 27, 2004, entitled “Piston-TypeDispenser with One-Way Valve for Storing and Dispensing Metered Amountsof Substances;” and U.S. patent application Ser. No. 12/724,370, filedMar. 15, 2010, entitled “Method for Delivering a Substance to an Eye,”which is a continuation of U.S. patent application Ser. No. 10/990,164,filed Nov. 15, 2004, entitled “Delivery Device and Method of Delivery,”now U.S. Pat. No. 7,678,089, which, in turn, claims the benefit ofsimilarly titled U.S. Provisional Patent Application No. 60/519,961,filed Nov. 14, 2003.

Alternatively, the storage chamber may be filled via a connector. Forexample, a sterile or aseptic connector may be constructed in accordancewith the teachings of any of the following patents and patentapplications, each of which is hereby expressly incorporated byreference in its entirety as part of the present disclosure: U.S.Provisional Patent Application No. 61/625,663, filed Apr. 17, 2012,entitled “Self Closing Connector,” similarly titled U.S. ProvisionalPatent Application No. 61/635,258, filed Apr. 18, 2012; U.S. ProvisionalPatent Application No. 61/641,248, filed May 1, 2012, entitled “Devicefor Connecting or Filling and Method;” and U.S. patent application Ser.No. 13/080,537, filed Apr. 5, 2011, entitled “Aseptic Connector withDeflectable Ring of Concern and Method,” which, in turn, claims thebenefit of similarly titled U.S. Provisional Patent Application No.61/320,857, filed Apr. 5, 2010.

The vial or other device embodying the present invention also may beused to store and dispense any of numerous different types of fluids orother substances for any of numerous different applications that arecurrently known, or later become known. In addition, the storage chamberneed not be a variable-volume storage chamber. For example, in anotherembodiment, the storage chamber defines a substantially fixed volume,but includes a sterile filter, such as a micro-filter of a type known tothose of ordinary skill in the pertinent art, that is coupled in fluidcommunication between the storage chamber and ambient atmosphere toallow air to flow into the storage chamber, but that sterilizes any suchair that flows therethrough in order to maintain the interior of thevariable-volume storage chamber sterile. Accordingly, this detaileddescription of embodiments is to be taken in an illustrative, as opposedto a limiting sense.

1. A device comprising: a body; a storage chamber defined within thebody for storing substance therein; a sterile filter coupled in fluidcommunication between the storage chamber and ambient atmosphere, andconfigured to allow air or other gas to flow from the ambient atmospheretherethrough into the storage chamber, and to sterilize air or other gasflowing into the storage chamber through the filter; and a one-way valveconnected or connectable in fluid communication with substance in thestorage chamber and configured to allow fluid to flow in one directiontherethrough but prevent ingress of fluid in an opposite direction,wherein the one-way valve is moveable between first and secondpositions, and further having a closed position preventing substancefrom passing therethrough and an open position permitting substance topass therethrough; wherein, in the first position, the one-way valve isprevented from opening from the closed position into the open position,so that substance cannot pass through the one-way valve at any time inthe first position, and in the second position the one-way valve ispermitted to open into the open position, so that substance from thestorage chamber may flow through and out of the one-way valve.
 2. Adevice as defined in claim 1, wherein the one-way valve includes anelastic valve member a normally closed, valve seam that substantiallyprevents the passage of fluid therethrough when a pressure differentialacross the valve is less than a valve opening pressure, and allows thepassage of fluid therethrough when a pressure differential across thevalve exceeds the valve opening pressure when the one-way valve is inthe second position.
 3. A device as defined in claim 2, wherein theone-way valve includes a valve seat, and the elastic valve memberengages the valve seat and forms the valve seam therebetween.
 4. Adevice as defined in claim 3, wherein one or more of (i) the elasticvalve member defines a progressively decreasing wall thickness in adirection from an inlet toward an outlet of the valve seam, or (ii) thevalve seat defines a progressively increasing width or diameter in adirection from an inlet toward an outlet of the valve seam.
 5. A deviceas defined in claim 1, further including a penetrable and resealableportion in fluid communication with the storage chamber that ispenetrable by a needle, filling or injection member to form apenetration aperture therein for introducing substance into the storagechamber and is hermetically resealable to hermetically seal thepenetration aperture.
 6. A device as defined in claim 5, wherein thepenetrable and resealable portion is resealable by one or more of aliquid sealant or the application of radiation or energy thereto.
 7. Adevice as defined in claim 1, further comprising a connector locateddownstream of an outlet of the one-way valve, wherein the connector isadapted for connection thereto by a syringe or other delivery device. 8.A device as defined in claim 7, wherein the connector is a Luerconnector.
 9. A device as defined in claim 1, wherein the one-way valveis normally biased in a direction from the second position toward thefirst position.
 10. A device as defined in claim 9, further including aspring that normally biases the one-way valve in a direction from thesecond position toward the first position.
 11. A device as defined inclaim 10, wherein the spring is formed integral with the valve member.12. A device as defined in claim 1, wherein (i) in the first position,the one- way valve is engaged with a surface of the device thatsubstantially prevents the one-way valve from opening into the openposition, and (ii) in the second position, the one-way valve issufficiently disengaged from the surface of the device to permit thevalve to open into the open position.
 13. A device as defined in claim12, wherein the one-way valve includes a valve seat and a valve membernormally engaging the valve seat to define the closed position, thevalve member being movable relative to the valve seat when a pressuredifferential across the one-way valve exceeds a valve opening pressurethereof when the one-way valve is in the second position, and in thefirst position, the surface of the device substantially preventsmovement of the valve member relative to the valve seat, and in thesecond position, the valve member is sufficiently disengaged from thesurface to permit movement of the valve member relative to the valveseat.
 14. A device as defined in claim 13, wherein the valve seat andvalve member are moveable together relative to the surface of the devicebetween the first and second positions.
 15. A device as defined in claim13, wherein the surface of the device engageable with the valve memberextends substantially annularly about the valve member.
 16. A device asdefined in claim 13, further comprising a connector located downstreamof an outlet of the one-way valve, wherein the connector is adapted forconnection thereto by a syringe or other delivery device, and connectionof the syringe or other delivery device causes the valve to move in adirection from the first position to the second position.
 17. A deviceas defined in claim 16, wherein the connector defines the surface of thedevice engageable with the valve member in the first position.
 18. Adevice as defined in claim 16, wherein the valve seat is configured sothat the syringe or other delivery device engages the valve seat whenconnected to the device and moves the valve in a direction from thefirst position toward the second position.
 19. A device as defined inclaim 16, wherein the connector is a Luer connector.
 20. A device asdefined in claim 19, wherein the connector a male or female Luerconnector adapted to connect to a respectively corresponding female ormale Luer connector of the syringe or other delivery device.
 21. Adevice as defined in claim 20, wherein the Luer connector is a threadedor slip fit Luer connector.
 22. A device as defined in claim 1, whereinthe sterile filter includes a micro-filter.
 23. A device as defined inclaim 1, wherein the base end comprises a base closure sealinglyenclosing the body at the base end thereof, and the base closureincludes the penetrable and resealable portion and the sterile filter.24. A device as defined in claim 1, defining a first end and a secondend opposite the first end relative to the storage chamber, wherein theone-way valve is located substantially at the first end and the sterilefilter is located substantially at the second end.
 25. A device asdefined in claim 24, further including a penetrable and resealableportion located substantially at the second end, wherein the penetrableand resealable portion is in fluid communication with the storagechamber, is penetrable by a needle, filling or injection member to forma penetration aperture therein for introducing substance into thestorage chamber, and is hermetically resealable to hermetically seal thepenetration aperture.
 26. A device comprising: first means for storingsubstance therein; second means for moving between first and secondpositions, for allowing substance to flow through the first means in onedirection therethrough and preventing ingress of substance in anopposite direction, and for preventing substance from passing throughthe second means in a closed position and for permitting substance topass through the second means in an open position; third means forpreventing the second means from opening into the open position in thefirst position, and for permitting the second means to open into theopen position in the second position; and fourth means for being influid communication between the first means and ambient atmosphere, forallowing air or other gas to flow therethrough into the first means, andfor sterilizing air or other gas flowing therethrough into the firstmeans.
 27. A device as defined in claim 26, further comprising fifthmeans for penetrating with a needle, filling or injection member, forforming a penetration aperture therein with the needle, filling orinjection member, for introducing substance into the first means, andfor hermetic resealing to hermetically seal the penetration aperture.28. A device as defined in claim 26, wherein the first means is a bodydefining a storage chamber therein, the second means is a one-way valve,the third means is a surface of one or more of a body of the device orthe connector that is engageable with the one-way valve in the firstposition, the fourth means is a sterile filter, and the fifth means is apenetrable and resealable portion.
 29. A method comprising: i. storingsubstance in a storage chamber of a device, the device furthercomprising: a sterile filter coupled in fluid communication between thestorage chamber and ambient atmosphere, and configured to allow air orother gas to flow from the ambient atmosphere therethrough into thestorage chamber, and to sterilize air or other gas flowing into thestorage chamber through the filter; and a one-way valve connected orconnectable in fluid communication with substance from the storagechamber and configured to allow fluid to flow in one directiontherethrough but prevent ingress of fluid in an opposite direction,wherein the one-way valve is moveable between first and secondpositions, and further having a closed position preventing substancefrom passing therethrough and an open position permitting substance topass therethrough, wherein, in the first position, the one-way valve isprevented from opening from the closed position into the open position,so that substance cannot pass through the one-way valve at any time inthe first position, and in the second position the one-way valve ispermitted to open into the open position, so that substance from thestorage chamber may pass through and out of the one-way valve; ii.moving the one-way valve from the first position to the second position;iii. in the second position, moving the valve from the closed positionto the open position; vi. passing substance from the storage chamberthrough the one-way valve; v. flowing air or other gas from ambientatmosphere into the storage chamber through the sterile filter; and vi.sterilizing the air or other gas flowing through the sterile filter intothe storage chamber.
 30. A method as defined in claim 29, wherein step(iii) includes generating a pressure differential across the one-wayvalve that exceeds a valve opening pressure thereof.
 31. A method asdefined in claim 29, wherein the one-way valve includes a valve seat anda valve member normally engaging the valve seat to define a closedposition, the valve member being movable relative to the valve seat whena pressure differential across the one-way valve exceeds a valve openingpressure thereof to define an open position, and step (ii) includesmoving the valve seat and valve member together relative to a surface ofthe device between the first and second positions.
 32. A method asdefined in claim 29, further including preventing the one-way valve fromopening from the closed position to the open position in the firstposition by engaging the one-way valve with a surface of the device. 33.A method as defined in claim 32, wherein step (ii) includes sufficientlydisengaging the one-way valve from the surface of the device to permitthe valve to open into the open position.
 34. A method as defined inclaim 33, wherein the one-way valve includes a valve seat and a valvemember normally engaging the valve seat to define the closed position,the valve member being movable relative to the valve seat when apressure differential across the one-way valve exceeds a valve openingpressure thereof when the one-way valve is in the second position, thepreventing step includes engaging the valve member with the surface ofthe device and substantially preventing movement of the valve memberrelative to the valve seat, and step (ii) includes sufficientlydisengaging the valve member from the surface of the device to permitmovement of the valve member relative to the valve seat.
 35. A method asdefined in claim 29, wherein the storage chamber and substance aresterile or aseptic, and the method further comprises maintaining thesubstance in the storage chamber sterile or aseptic at least throughoutsteps (i) through (vi).
 36. A method as defined in claim 29, whereinstep (ii) comprises engaging the one-way valve with the syringe or otherdelivery device.
 37. A method as defined in claim 29, wherein the devicedefines a first end and a second end opposite the first end relative tothe storage chamber, wherein the one-way valve is located substantiallyat the first end and the sterile filter is located substantially at thesecond end.
 38. A method as defined in claim 34, wherein the devicefurther comprises a penetrable and resealable portion locatedsubstantially at the second end and in fluid communication with thestorage chamber, and the method further comprises: penetrating thepenetrable and resealable portion with a needle, filling or injectionmember; introducing substance through the needle, filling or injectionmember and into the storage chamber; and hermetically resealing aresulting penetration aperture in the penetrable and resealable portion.39. A method as defined in claim 29, further comprising preventinggerms, contaminants, air, or other gas from entering the device throughthe one-way valve.
 40. A method as defined in claim 29, furthercomprising biasing the one-way valve in a direction from the secondposition toward the first position.
 41. A method as defined in claim 29,further comprising connecting a syringe or other delivery device influid communication with the one-way valve and performing step (ii) withthe syringe or other delivery device, and performing step (iii) bycreating at least a partial vacuum in the syringe or other deliverydevice and generating a pressure differential across the one-way valvethat exceeds a valve opening pressure thereof.